BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE II MONITOR

    MDR report key: 3091129 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00923
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BZK
    PMA / PMN Number
    062754
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVES REPLACED BROKEN O2 CONNECTOR. REPLACED THE SMALL DIAMETER TUBING BETWEEN THE O2 FILTER AND THE O2 SENSOR. PERFORMED THE RECOMMENDED 12 AND 24 MONTH PREVENTIVE MAINTENANCE. TESTED, CALIBRATED AND SAFETY CHECKED UNIT TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW FLOW GAS READINGS FROM THE GAS MODULE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187755 GAS MODULE II MONITOR GAS MODULE BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1